The Ministry of Food and Drug Safety (MFDS) is amending the “Regulation on Medical Device Group and Class by Group” as follows: 1) Establishment of new items – Establishment of five new medical device items to classify temporarily designated items. 2) Adjustment of the class of medical devices – One item was reclassified considering international harmonization and equity with other medical devices. 3) Modification of item definition (including clerical error) – The definitions of five medical device items were modified.
South Korea – Proposed Amendments to the “Regulation on Medical Device Group and Class by Group”
